Phase 1b Study of HS-20093 Combined With Other Cancer Drugs for Advanced Metastatic Colorectal Cancer

What this Trial Is About

Researchers are studying HS-20093, a fully humanized antibody-drug conjugate that targets B7-H3, a protein commonly found on solid tumor cells. This phase 1b, open-label study focuses on patients with advanced metastatic colorectal cancer to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HS-20093 when combined with other anti-cancer drugs. The study involves five different combination treatments of HS-20093 with medications such as Bevacizumab, 5-fluorouracil 5-FU, Leucovorin, Capecitabine, and Oxaliplatin. All these drugs are given either by intravenous infusion or orally, depending on the medication. The study includes a dose-escalation phase for patients who have already tried standard treatments without success, and a dose-expansion phase for those who have not received prior treatment for advanced metastatic colorectal cancer. Participants will be monitored closely for side effects during treatment and for 90 days afterward. They may continue therapy if it is well tolerated and clinical benefit is observed. Researchers will assess the maximum tolerated dose, adverse events, tumor response, disease control, survival times, and drug levels in the blood for up to 24 months. The total duration and specific follow-up visits will vary based on individual treatment courses.

ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer